Europe Consults on Digital Health

Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU. The earliest deadline for submissions is 16 August 2017.

EU Commission Transformation of Health Care in the Digital Single Market Consultation

On 20 July 2017, the European Commission launched a consultation on the “Transformation of Health and Care in the Digital Single Market”. This Consultation covers three broad areas:

From the roadmap, it does not look like any legislation is anticipated (e.g. there is no reference to an “e-health Directive” that would provide for a pan-EU basis for secondary use of patient data). The roadmap is also silent on the European Commission’s wider free flow of data legislative intentions. The Commission is accepting feedback on the roadmap until 16 August 2017.

EU Presidency Digital Health Society Consultation

Finally, we note that the Estonian Presidency of the Council of the European Union has also launched a brief Digital Health Society consultation. This consultation includes questions relating to whether citizens are sufficiently informed of the benefits of the sharing of data for health care services or research, ensuring there is adequate precaution to guarantee the privacy, confidentiality, and security of data, and interoperability challenges. This consultation is open until 30 August 2017.

Getting involved

Interested parties, including digital health solution providers, operators and users of digital health tools, public authorities, hospitals, insurers and researchers and research institutions should consider making submissions to these consultations help shape digital health policy in the EU on wide-ranging matters including data privacy, medical device and healthcare regulation, and consumer rights.